DePuy Global™ FX Shoulder Fracture System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

Johnson & Johnson International (Singapore) Pte Ltd

Class:

Class C medical device

Manufactured by:

DePuy Orthopaedics, Inc.

Therapeutic area:

Orthopaedics

Therapeutic indications:

Total shoulder or hemi-shoulder replacement is indicated for 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory. 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component) Hemi-shoulder replacement is also indicated for 1. Ununited humeral head fractures; 2. Avascular necrosis of the humeral head; 3. Rotator cuff arthropathy. GLOBAL C.A.P.TM is indicated for intact or repairable rotator cuff. 4. Deformity and/or limited motion

Product summary:

Device System Info:[Sterile Medical Device], Products are sterilized by Gamma Radiation.; Models: Global™ FX Stem 6 x 6LNG x 160 - 112806010, Global™ FX Humeral Stem W/Porocoat® 6mm - 112806050, Global™ FX Humeral Stem W/Porocoat® 6mm LNG - 112806060, Global™ FX Stem 8 x 8 x 130 - 112808000, Global™ FX Stem 8 x 8LNG x 200 - 112808010, Global™ FX Humeral Stem W/Porocoat® 8mm - 112808050, Global™ FX Humeral Stem W/Porocoat® 8mm LNG - 112808060, Global™ FX Stem 10 x 10 x 140 - 112810000, Global™ FX Stem 10 x 10LNG x 210 - 112810010, Global™ FX Humeral Stem W/Porocoat® 10mm - 112810050, Global™ FX Humeral Stem W/Porocoat® 10mm LNG - 112810060, Global™ FX Stem 6 x 6 x 120 - 112806000, Global™ FX Stem 12 x 12 x 150 - 112812000, Global™ FX Stem 12 x 12LNG x 220 - 112812010, Global™ FX Humeral Stem W/Porocoat® 12mm - 112812050, Global™ FX Humeral Stem W/Porocoat® 12mm LNG - 112812060, Global™ Advantage® Shoulder-Humeral Head 40 x 15 - 112840000, Global™ Advantage® Shoulder-Humeral Head 40 x 18 - 112840010, Global™ Advantage® Shoulder-Humeral Head 40 x 21 - 112840020, Global™ Advantage® Shoulder-Humeral Head 44 x 15 - 112844000, Global™ Advantage® Shoulder-Humeral Head 44 x 18 - 112844010, Global™ Advantage® Shoulder-Humeral Head 44 x 21 - 112844020, Global™ Advantage® Shoulder-Humeral Head 48 x 15 - 112848000, Global™ Advantage® Shoulder-Humeral Head 48 x 18 - 112848010, Global™ Advantage® Shoulder-Humeral Head 48 x 21 - 112848020, Global™ Advantage® Shoulder-Humeral Head 52 x 15 - 112852000, Global™ Advantage® Shoulder-Humeral Head 52 x 18 - 112852010, Global™ Advantage® Shoulder-Humeral Head 52 x 21 - 112852020, Global Shoulder Anchor Peg Glenoid 40MM - 113640025, Global Shoulder Anchor Peg Glenoid 44MM - 113641025, Global Shoulder Anchor Peg Glenoid 48MM - 113642025, Global Shoulder Anchor Peg Glenoid 52MM - 113643025, Global Shoulder Anchor Peg Glenoid 56MM - 113644025, Global Shoulder Anchor Peg Glenoid 56MMXL - 113645025, AML® Excel Femoral/ Humeral Head Impactor - 200165000, Global™ Advantage® Reamer 6mm - 212801006, Global™ Advantage® Reamer 8mm - 212801008, Global™ Advantage® Reamer 10mm - 212801010, Global™ Advantage® Reamer 12mm - 212801012, Global™ Advantage® Reamer 14mm - 212801014, Global™ Advantage® Reamer 16mm - 212801016, Global FX Inserter/Extractor - 212801020, Global™ Advantage® Humeral Head Distractor - 212801021, Global FX Head Impaction Stand - 212801022, Global FX Templates - 212801023, Global FX Case & Tray - 212801030, Global FX Positioning Jig - 212801035, Global FX Jig Hex Driver - 212801036, Global FX Jig Alignment Rod - 212801037, Global™ Advantage® FX Head Gauge - 212802044, Global FX™ Stem Trial 6mm - 212806000, Global FX™ Stem Trial 6mm x 160 - 212806010, Global FX™ Stem Trial 8mm - 212808000, Global FX™ Stem Trial 8mm x 200 - 212808010, Global™ Advantage® Extractor Poly Tip - 212808021, Global FX™ Stem Trial 10mm - 212810000, Global FX™ Stem Trial 10mm x 210 - 212810010, Global FX™ Stem Trial 12mm - 212812000, Global FX™ Stem Trial 12mm x 200 - 212812010, Global™ Advantage® Extractor Metal Tip - 212812020, Global™ Advantage® Humeral Head Trial - 212840000, Global™ Advantage® Humeral Head Trial 40 x 18 - 212840010, Global™ Advantage® Humeral Head Trial 40 x 21 - 212840020, Global™ Advantage® Humeral Head Trial 44 x 15 - 212844000, Global™ Advantage® Humeral Head Trial 44 x 18 - 212844010, Global™ Advantage® Humeral Head Trial 44 x 21 - 212844020, Global™ Advantage® Humeral Head Trial 48 x 15 - 212848000, Global™ Advantage® Humeral Head Trial 48 x 18 - 212848010, Global™ Advantage® Humeral Head Trial 48 x 21 - 212848020, Global™ Advantage® Humeral Head Trial 52 x 15 - 212852000, Global™ Advantage® Humeral Head Trial 52 x 18 - 212852010, Global™ Advantage® Humeral Head Trial 52 x 21 - 212852020, Global™ Advantage® Center/Peripheral Drill Bit - 212861007, Global™ Anchor Peg Glenoid Trial 40MM - 223680000, Global™ Anchor Peg Glenoid Trial 44MM - 223680010, Global™ Anchor Peg Glenoid Trial 48MM - 223680020, Global™ Anchor Peg Glenoid Trial 52MM - 223680030, Global™ Anchor Peg Glenoid Trial 56MM - 223680040, Global™ Anchor Peg Glenoid Trial 56XLMM - 223680050, Global™ Anchor Peg Center Drill Guide - 223680060, Global™ Anchor Peg Center Drill Bit - 223680070, Global™ Advantage ® Anchor Peg Center Drill Bit - 223680075, Global™ Anchor Peg Peripheral Guide - 223680080, Global™ Anchor Peg Peripheral Drill Bit - 223680090, Global™ Anchor Peg Antirotation Post - 223680091, Global™ Anchor Peg Glenoid Case - 223680095, Global™ Anchor Peg Overlay - 223680098, T-Handle W/Female Hudson - 227432000

Authorization date:

2010-07-31